[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Serbia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":639},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,235,0,25,[9,49,73,102,134,157,180,211,235,256,278,306,327,351,382,394,417,439,463,487,508,530,559,586,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053313","phase-3-study-to-evaluate-the-efficacy-and-safety-of-abelacimab-in-high-risk-patients-with-atrial-fibrillation-who-have-been-deemed-unsuitable-for-oral-anticoagulation-lilac-timi-76-100053313",false,"NCT05712200","Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","LILAC-TIMI 76","Inclusion Criteria:\n\n* Patient is able to understand and has provided written informed consent to participate in the trial\n* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)\n* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3\n* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study\n* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls\n* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study\n\nExclusion Criteria:\n\n* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)\n* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF\n* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment\n* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization\n* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study\n* Patients on dialysis at screening or who are planned to start dialysis within 6 months\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","ALL","65 Years",{"count":21,"type":22},2500,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.",[28],"Atrial Fibrillation (AF)",[30,31,32,33,34,35],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation","atrial fibrillation","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2022-12-27",{"date":44,"type":22},"2027-12-30",{"name":46,"class":47},"Anthos Therapeutics, Inc.","INDUSTRY",789,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100053951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100053951","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.","18 Years","75 Years",{"count":60,"type":22},256,[25],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[64],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":39,"type":40},{"date":67,"type":40},"2025-02-10",{"date":69,"type":22},"2030-12-31",{"name":71,"class":47},"Dianthus Therapeutics",180,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100053519","phase-2-study-to-evaluate-the-efficacy-safety-and-tolerability-of-pipe-791-in-subjects-with-idiopathic-pulmonary-fibrosis-100053519","NCT07284459","Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis","Key Inclusion Criteria:\n\n* Male or female ≥ 40 years of age at the time of Randomization.\n* A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS\u002FERS\u002FJRS\u002FALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.\n* Percent predicted (pp) FVC ≥ 40% on Screening spirometry.\n* Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.\n\nKey Exclusion Criteria:\n\n* Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.\n* Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.\n* Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.\n* Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml\u002Fmin\u002F1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.\n* Female participants must not be of childbearing potential.\n\nAdditional inclusion and exclusion criteria apply.","40 Years",{"count":82,"type":22},324,[84],"PHASE2","This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.",[87],"Idiopathic Pulmonary Fibrosis",[87,89,90,91,92,93],"PIPE 791","Pulmonary Fibrosis","IPF","ILD","Interstitial lung disease",{"date":39,"type":40},{"date":96,"type":40},"2026-01-08",{"date":98,"type":22},"2028-06",{"name":100,"class":47},"Contineum Therapeutics",49,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100054235","phase-3-zilebesiran-in-patients-with-hypertension-not-adequately-controlled-and-with-either-established-cardiovascular-disease-or-high-risk-for-cardiovascular-disease-100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":111,"type":22},11000,[25],"The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.",[115,116,117],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[119,120,121,122,123,124,125],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":39,"type":40},{"date":128,"type":40},"2025-09-22",{"date":130,"type":22},"2030-09-30",{"name":132,"class":47},"Alnylam Pharmaceuticals",995,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100053921","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years","80 Years",{"count":144,"type":22},1200,[25],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[148],"Crohn's Disease",{"date":39,"type":40},{"date":151,"type":40},"2024-06-05",{"date":153,"type":22},"2029-11-12",{"name":155,"class":47},"Merck Sharp & Dohme LLC",499,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100053407","phase-2-efficacy-safety-and-pharmacokinetics-of-vericiguat-in-pediatric-participants-with-heart-failure-due-to-left-ventricular-systolic-dysfunction-mk-1242-036-100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":167,"type":22},342,[84,25],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[171,172],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":39,"type":40},{"date":175,"type":40},"2023-05-31",{"date":177,"type":22},"2032-04-15",{"name":155,"class":47},107,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":19,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":191,"conditions":192,"keywords":198,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100054020","evaluating-percutaneous-repair-of-the-atrial-septum-with-a-novel-pfo-occluder-the-protea-pfo-ous-study-100054020","NCT07698951","Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study","PROTEA-PFO OUS","Inclusion Criteria:\n\n1. Patient must be ≥ 18 and ≤ 65 years of age\n2. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and\u002For during Valsalva release.\n3. Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct.\n4. Modified Rankin score (mRS) ≤ 3.\n5. Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.\n6. Patient is willing and capable of providing informed consent.\n7. Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test.\n\nExclusion Criteria:\n\n1. Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \\>4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection, presence of left atrial appendage thrombus.\n2. Other arteriopathy of the intracranial or extracranial vessels with \\>50% stenosis proximal to the territory of the index stroke.\n3. Intracardiac thrombus or tumor.\n4. Myocardial Infarction (MI) or unstable angina within the previous 180 days.\n5. Life expectancy \\\u003C 2 years.\n6. Left ventricular aneurysm or akinesis.\n7. Moderate to severe mitral valve stenosis or severe mitral regurgitation.\n8. Aortic valve stenosis (mean gradient \\>20 mmHg) or severe regurgitation.\n9. Active endocarditis or other infection that may preclude implantation of the investigational device.\n10. Any valve vegetation or Lambl's excrescence of any left-sided valve.\n11. Left ventricular dilated cardiomyopathy with LVEF \\\u003C35%.\n12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and\u002For fenestrated septum and pulmonary arteriovenous malformation.\n13. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.\n14. Severe renal failure ( Stage 4 CKD, eGFR \\\u003C30) or patient requiring dialysis.\n15. Severe liver disease (e.g., documented cirrhosis or active hepatitis).\n16. Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).\n17. Uncontrolled hypertension, defined as sustained elevated blood pressure \\>140\u002F90 mm Hg.\n18. Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of \\>50mmHg.\n19. Uncontrolled hyperglycemia, defined as HbA1c value \\>8% (IFCC: \\>64 mmol\u002Fmol).\n20. Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy.\n21. Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.\n22. Subjects contraindicated for aspirin or clopidogrel.\n23. Subjects not able to discontinue anticoagulation for indications other than then index stroke.\n24. Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies).\n25. Currently an active subject in an investigational drug or device study that could confound the results of this study.\n26. Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance\u002Fsevere pulmonary hypertension.\n27. Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).\n28. Any prior percutaneous cardiovascular intervention for AF ablation.\n29. Known nickel allergy that, in the opinion of the investigator, poses a safety risk with regards to participation in the trial.",{"count":188,"type":22},15,[190],"NA","The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is:\n\n• Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO.\n\nParticipants will:\n\n* Undergo the procedure to implant the P3 Occluder System, if deemed appropriate.\n* Visit their doctor at 1 month, 3 months, 6 months, and 1 year after the procedure for follow up exams.\n* Answer a phone call from study staff at 2 years and 3 years after the procedure to answer a survey.",[193,194,195,196,197],"PFO","PFO - Patent Foramen Ovale","Cryptogenic Stroke","Patent Foramen Ovale","PFO-associated Stroke",[196,193,195,199,200,201],"PFO Occluder","Transcatheter","PFO-associated stroke","2026-07-07",{"date":39,"type":40},{"date":205,"type":40},"2026-06-17",{"date":207,"type":22},"2029-12",{"name":209,"class":47},"Recross Cardio, Inc.",1,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":141,"maxAge":142,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100579098","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-and-maintenance-therapy-with-afimkibart-ro7790121-in-participants-with-moderately-to-severely-active-crohns-disease-100579098","NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy",{"count":220,"type":22},600,[25],"This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[224],"Moderately to Severely Active Crohns Disease","2026-07-01",{"date":227,"type":40},"2026-07-02",{"date":229,"type":40},"2025-03-17",{"date":231,"type":22},"2033-12-31",{"name":233,"class":47},"Hoffmann-La Roche",372,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":141,"maxAge":142,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100561337","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-therapy-with-afimkibart-also-known-as-ro7790121-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100561337","NCT06588855","A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis","Ametrine-2","Inclusion Criteria:\n\n* Confirmed diagnosis of UC\n* Moderately to severely active UC assessed by mMS\n* Bodyweight \\>= 40 kilogram (kg)\n* Up to date with colorectal cancer (CRC) screening performed according to local standards\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced UC therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)\n* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed\n* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy",{"count":244,"type":22},350,[25],"This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).",[248],"Moderately to Severely Active Ulcerative Colitis",{"date":227,"type":40},{"date":251,"type":40},"2024-12-11",{"date":253,"type":22},"2031-01-30",{"name":233,"class":47},200,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":141,"maxAge":142,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100607159","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-crohns-disease-100607159","NCT07184931","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","STARSCAPE-1","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)\n\nExclusion Criteria:\n\n* Participants with Ulcerative Colitis (UC) or indeterminate colitis\n* Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapy prior to baseline\n* Participants receiving prohibited medications or therapies\n* Participants with previous exposure to anti-TL1A investigational therapy\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":265,"type":22},980,[25],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Up to 5-week Screening Period.\n* 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction).\n* 12-week Sub-Study 3 (Extended Induction for non-responders).\n* 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.\n\nThe number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.",[148],"2026-06-30",{"date":225,"type":40},{"date":272,"type":40},"2025-10-01",{"date":274,"type":22},"2029-05-14",{"name":276,"class":47},"Sanofi",301,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100604873","phase-2-a-study-to-evaluate-the-optimal-dose-adverse-events-and-change-in-disease-activity-of-intravenous-abbv-706-in-combination-with-atezolizumab-versus-standard-of-care-as-first-line-treatment-in-adult-participants-with-previously-untreated-extensive-stage-small-cell-lung-cancer-100604873","NCT07155174","A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","SEZanne","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* Suspected brain metastases at screening should have a computed tomography (CT)\u002F magnetic resonance imaging (MRI) of the brain prior to study entry.\n\nExclusion Criteria:\n\n* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases should be excluded.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan should be excluded.\n* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.",{"count":72,"type":22},[84],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.\n\nIn the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[290],"Small Cell Lung Cancer",[290,292,293,294,295,296,297],"SCLC","ABBV-706","Etoposide","Carboplatin","Atezolizumab","Lurbinectedin",{"date":227,"type":40},{"date":300,"type":40},"2025-11-25",{"date":302,"type":22},"2031-09",{"name":304,"class":47},"AbbVie",57,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":19,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100493377","phase-1-a-study-to-investigate-the-safety-tolerability-and-processing-by-the-body-of-intravenous-and-subcutaneous-ro7121932-administration-in-participants-with-multiple-sclerosis-100493377","NCT05704361","A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis","A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis","Inclusion Criteria:\n\n* Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening\n* Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)\n* Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)\n* Female participants must practice abstinence or otherwise use contraception\n\nExclusion Criteria:\n\n* Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \\>1 clinical relapse within 12 months prior to screening\n* Evidence of magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan\n* Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML\n* Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism\n* Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1\n* Participants with a current diagnosis of epilepsy\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \\>1 year prior to screening is not exclusionary\n* Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study\n* History of currently active primary or secondary (non-drug-related) immunodeficiency\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation\n* Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.\n\nPrior\u002FConcomitant Therapy:\n\n* Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial\n* Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab\n* Previous treatment with anti-cluster of differentiation 20 (CD20) B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)\n\n  * \\\u003C12 months prior to acquiring any screening laboratory tests,\n  * ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),\n  * If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons\n* Current or prior treatment with natalizumab (if \\\u003C24 months prior to acquiring any screening laboratory tests)\n\nPrior\u002FConcurrent Clinical Study Experience:\n\n\\- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokinetic (PK) half-life (if known), whichever is longer\n\nDiagnostic Assessments:\n\n* Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B\n* Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk\n* Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1",{"count":314,"type":22},129,[316],"PHASE1","The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).",[319],"Multiple Sclerosis",{"date":225,"type":40},{"date":322,"type":40},"2021-08-11",{"date":324,"type":22},"2027-07-08",{"name":233,"class":47},32,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":350},"100476995","phase-4-comparison-of-reduced-dapt-followed-by-p2y12-inhibitor-monotherapy-with-prasugrel-vs-standard-regimen-in-stemi-patients-100476995","NCT05491200","Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients","COMPARE STEMI ONE- Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients Treated With OCT-guided vs aNgio-guided completE Revascularization","Inclusion Criteria:\n\nEligibility at index procedure\n\nAll STEMI patients who are planned to be treated with PCI:\n\nST segment elevation myocardial infarction\n\nChest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features:\n\n* ST segment elevation ≥2 contiguous ECG leads\n* new or presumably new left bundle branch block\n\nIn patients with multivessel disease, treatment only of the culprit lesion \u002F target vessel during primary PCI is recommended.\n\nEligibility at 30-45 days\n\n* All patients who have provided informed consent\n* Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)\n* No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication\u002Fbleeding BARC Types 3 or greater).\n* Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of \\\u003C30% (visually) for all target lesions.\n* Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%.\n\nExclusion criteria\n\n* Patients on oral anticoagulation\n* Contraindication to P2Y12 inhibitors and\u002For to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg\u002Fweek or more).\n* Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2).\n* Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice \\>1L\u002Fday), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin), - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital\n* Platelet count \\\u003C100.000\u002FμL at the time of screening\n* Anemia (hemoglobin \\\u003C10 g\u002FdL) at the time of screening\n* Comorbidities associated with life expectancy \\\u003C1 year\n* Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential)\n* PCI indication for stent thrombosis or previous history of definite stent thrombosis\n* Non-deferrable major surgery on DAPT after PCI\n* Cardiogenic shock\n* Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC)\n* Patients with severe renal impairment: creatinine clearance ≤30 ml\u002Fmin\u002F1.73 m2 (as calculated by MDRD formula for estimated GFR).\n* Patients participating in another interventional (device of drug trial) within the previous 12 months or patients to whom an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer.\n* No informed consent",{"count":335,"type":22},1656,[337],"PHASE4","The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints.\n\nIn the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.",[340,341],"ST Elevated Myocardial Infarction","Dual Antiplatelet Therapy",{"date":227,"type":40},{"date":344,"type":40},"2022-07-22",{"date":346,"type":22},"2029-08-01",{"name":348,"class":349},"Research Maatschap Cardiologen Rotterdam Zuid","OTHER",27,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":358,"minAge":359,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":368,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":381},"100450410","phase-3-open-label-extension-study-of-marstacimab-in-hemophilia-participants-with-or-without-inhibitors-100450410","NCT05145127","Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors","AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN SEVERE (COAGULATION FACTOR ACTIVITY \u003C1%) HEMOPHILIA A PARTICIPANTS WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS","Inclusion Criteria:\n\n* All participants will have a minimum body weight as defined by parent studies\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Participants have successfully completed participation in parent studies, defined as did not require \"Early Termination\"\n\nExclusion Criteria:\n\n* Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade \\>3), or ischemic disease (except catheter-associated thrombosis)\n* Abnormal renal function as defined by eGFR \\\u003C30 mL.min\u002F1.73 m(2)\n* Known planned surgical procedure during the planned study period\n* Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study\n* For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available CD4 count (if available), which would make the participant inappropriate for the study\n* Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)\n* Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study\n* Participation in other study involving investigational drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in parent studies\n* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members","MALE","1 Year","74 Years",{"count":362,"type":22},245,[25],"Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require \"Early Termination\" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008.\n\nStudy B7841005: approximately 145 adolescent and adult participants 12 to \\\u003C75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity \\\u003C1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab).\n\nStudy B7841008: this is an ongoing Phase 3, open-label study in pediatric participants \\\u003C18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity \\\u003C1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to \\\u003C18 years and at least 80 participants will be aged ≥1 to \\\u003C12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to \\\u003C18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit\u002Frisk assessment in support of dosing participants aged ≥6 to \\\u003C12 years. Based on the positive benefit\u002Frisk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to \\\u003C12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to \\\u003C6 years.\n\nAll participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.",[366,367],"Hemophilia A","Hemophilia B",[369,370,371,372,373],"Factor VIII Inhibitor","Factor IX Inhibitor","PF-06741086","Marstacimab","Anti-TFPI",{"date":225,"type":40},{"date":376,"type":40},"2021-11-17",{"date":378,"type":22},"2030-07-31",{"name":380,"class":47},"Pfizer",75,{"id":383,"slug":4,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":80,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":85,"conditions":386,"keywords":387,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":391,"leadSponsor":392,"locationsCount":393},"100614812",{"count":82,"type":22},[84],[87],[87,89,90,91,92,93],"2026-06-29",{"date":225,"type":40},{"date":96,"type":40},{"date":98,"type":22},{"name":100,"class":47},47,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100547974","phase-2-safety-and-efficacy-of-3-dose-levels-of-nmd670-in-adult-patients-with-myasthenia-gravis-100547974","NCT06414954","Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR\u002FMuSK-Ab+ Myasthenia Gravis","SYNAPSE-MG","Inclusion Criteria:\n\n* Participant must be a male or female being 18 or more, at the time of signing the informed consent\n* Diagnosis of MG, MGFA class II, III or IV\n* Documented positive AChR or MuSK antibody test.\n* Participant must be able to swallow tablets\n* Body mass index between 18 and 35 kg\u002Fm2, inclusive, at screening, and with a minimum weight of 40 kg\n* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* Participant is capable of and has given signed informed consent\n\nExclusion Criteria:\n\n* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study\n* Participants with other significant clinical and\u002For laboratory safety findings that may interfere with the conduction or interpretation of the study\n* Participants that received treatment with an investigational medical product within 30 days or 5 half-lives of the medication, whichever is longer prior to Day 1\n* Participants with history of poor compliance with relevant MG therapy\n* Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding",{"count":403,"type":22},84,[84],"This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.",[407,408],"Myasthenia Gravis","Myasthenia Gravis, MuSK",{"date":225,"type":40},{"date":411,"type":40},"2024-05-16",{"date":413,"type":22},"2026-12",{"name":415,"class":47},"NMD Pharma A\u002FS",40,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":424,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":305},"100595217","phase-2-phase-2-efficacy-and-safety-study-of-acp-204-in-lewy-body-dementia-psychosis-100595217","NCT07029581","Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis","A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)","Inclusion Criteria:\n\n* Male or female ≥55 years to \\\u003C85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting\n* Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:\n\n  1. The subject's LAR must provide written informed consent.\n  2. The subject must provide written (if capable) informed assent per local regulations.\n* Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium).\n* Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association\n\nExclusion Criteria:\n\n* Is in hospice, is receiving end-of-life palliative care, or is bedridden\n* Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia\n* Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)\n* Has a history or current evidence of a serious and\u002For significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures\n* Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT","55 Years","84 Years",{"count":72,"type":22},[84],"Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.",[430],"Lewy Body Dementia Psychosis","2026-06-26",{"date":269,"type":40},{"date":434,"type":40},"2025-08-06",{"date":436,"type":22},"2028-03",{"name":438,"class":47},"ACADIA Pharmaceuticals Inc.",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":462},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":448,"type":22},645,[84],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[452,453,454,455],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":388,"type":40},{"date":458,"type":40},"2025-05-27",{"date":436,"type":22},{"name":461,"class":47},"Spyre Therapeutics, Inc.",243,{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":23,"phases":471,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":416},"100616379","phase-1-a-two-part-study-to-investigate-the-effects-in-adults-of-two-doses-of-golexanolone-in-patients-with-primary-biliary-cholangitis-pbc-with-fatigue-and-cognitive-dysfunction-100616379","NCT07304843","A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction","A Randomised, Double-blind, Placebo-controlled, Two-part Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Preliminary Efficacy of Two Dose Levels of Golexanolone in Subjects With Primary Biliary Cholangitis (PBC), Fatigue, and Cognitive Dysfunction","Inclusion Criteria:\n\n* Male and female subjects age ≥ 18 years\n* Diagnosis of PBC based on the presence of ≥2 of 3 key disease characteristics\n* Clinically significant fatigue defined for the purposes of this study as a PBC-40 fatigue domain score of ≥29 at screening\n* Clinically significant cognitive symptoms, defined for the purposes of this study as a PBC-40 cognitive domain ≥16 at screening\n* Stable PBC SoC therapy (if any),for at least 3 months prior to randomisation\n* For all women of childbearing potential (WOCBP) a negative pregnancy test at screening and a negative urine dip-stick pregnancy test at baseline, prior to first dose of IMP\n* WOCBP must be willing to use a contraceptive method with a failure rate of \\\u003C 1% and agree to continue use of this method for the duration of the study and thereafter for 1 month after the last dosing of the IMP\n* Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal\n* Fertile male subjects must be willing to use condom and assure that their female partner will use contraceptive methods with a failure rate of \\\u003C 1%\n* Willing and able to give informed consent\n* The subject should be judged by the Investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent\n\nExclusion Criteria:\n\n* Child-Pugh class B or C cirrhosis\n* Clinical evidence of hepatic decompensation (e.g. current or prior HE, ascites, or variceal bleeding)\n* History of hepatocellular carcinoma\n* Bilirubin \\>1.5 x ULN\n* Glomerular filtration rate (GFR) \\\u003C35 mL\u002Fmin\u002F1.73m2\n* Low Haemoglobin (HB), i.e. subjects with moderate\u002Fsevere anaemia\n* Low S-B12 or low P-folate\n* Evidence of biliary obstruction\n* Any positive result on screening for human immunodeficiency virus (HIV), or hepatitis B (serum hepatitis B surface antigen positive)\n* Prolonged QTcF (\\>500 ms), or any clinically significant abnormality in the resting ECG, as judged by the Investigator (at screening)\n* Concomitant disease characterised by chronic fatigue and\u002For cognitive impairment\n* Clinically significant bowel disease, including obstruction, active inflammatory bowel disease, or malabsorption\n* Clinically significant sleep apnoea\n* An uncontrolled thyroid disorder\n* Subjects with a history of or currently active immune disorders (i.e. uncontrolled) other that PBC (including autoimmune disease) and\u002For diseases requiring immunosuppressive drugs\n* Clinical diagnosis of autoimmune hepatitis overlap\n* The presence, as judged by the Investigator, of clinically significant concomitant illness which would jeopardise safe participation in the study and \u002For the interpretation of study findings\n* Regular use of prescribed or over the counter (OTC) medications known to cause fatigue or cognitive dysfunction\n* Use of prohibited medications within 14 days prior to randomisation\n* Anticipated change in PBC medication and\u002For significant medical or surgical intervention within the duration of the study\n* Regular (more than 1 week per month) alcohol consumption in excess of 14 units per week\n* Administration of another new chemical entity or has participated in any other clinical study that included drug treatment with the last administration within 3 months prior to administration of IMP in this study\n* Females who are pregnant, nursing or actively trying to conceive a child\n* Expected inability to swallow the required number of IMP capsules at the applicable dose level\n* History of severe allergy\u002Fhypersensitivity or on-going allergy\u002Fhypersensitivity, as judged by the Investigator",{"count":403,"type":22},[316,84],"The present phase 1b\u002F2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone compared with placebo among subjects with a history of non-cirrhotic or Child-Pugh class A cirrhotic Primary Biliary Cholangitis (PBC) with clinically significant fatigue and cognitive symptoms on stable background standard of care (SoC) PBC medication. The objectives of this research study are to assess the safety and tolerability as well the pharmacokinetic (PK) characteristics of golexanolone administered 40 mg BID for 5 days in the target population (part A) and to assess the safety and tolerability, the effects of golexanolone on health-related quality of life (HRQoL), including fatigue, day-time sleepiness and cognitive function as well as Investigator's overall impression of treatment effect of 28 days twice per day (BID) treatment with two dose levels of golexanolone versus placebo (part B).",[474],"Primary Biliary Cholangitis (PBC)",[476,477,478],"PBC","Cognition","Fatigue","2026-06-25",{"date":431,"type":40},{"date":482,"type":40},"2023-04-14",{"date":484,"type":22},"2026-09-30",{"name":486,"class":47},"Umecrine Cognition AB",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":507},"100609703","phase-3-a-clinical-study-of-sotatercept-mk-7962-in-people-with-pulmonary-arterial-hypertension-mk-7962-038-100609703","NCT07218029","A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)","An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)","SOTERIA","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early\n* Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements\n* Must have the ability to understand and provide documented informed consent\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Did not participate in a sotatercept PAH parent study\n* Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.\n* Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept\n* Is a female who is pregnant or breastfeeding\n* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study\n* Is currently enrolled in another investigational product study other than a sotatercept study\n* Is incapacitated",{"count":496,"type":22},815,[25],"Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.\n\nSotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.\n\nThis is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.",[500],"Pulmonary Arterial Hypertension",{"date":431,"type":40},{"date":503,"type":40},"2021-05-12",{"date":505,"type":22},"2028-12-07",{"name":155,"class":47},126,{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":529},"100583779","phase-3-study-of-plozasiran-in-adults-with-severe-hypertriglyceridemia-at-risk-of-acute-pancreatitis-100583779","NCT06880770","Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis","Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)","SHASTA-5","Inclusion Criteria:\n\n* Males, or nonpregnant (who do not plan to become pregnant) nonlactating females\n* Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg\u002FdL (≥ 10 mmol\u002FL)\n* Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening.\n* Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg\u002FdL (≤ 3.37 mmol\u002FL) at Screening\n* Screening hemoglobin A1c (HbA1c) ≤ 9.5%\n* Willing to follow diet counseling and maintain a stable low-fat diet\n* Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the Investigator)\n\nExclusion Criteria:\n\n* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and\u002For triglycerides within 365 days before Day 1, except inclisiran.\n* Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer.\n* AP ≤ 4 weeks prior to Randomization\u002FDay 1\n* Body mass index (BMI) \\> 45 kg\u002Fm\\^2\n* Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)\n* Planned coronary intervention (e.g. stent placement or heart bypass) during the study\n* History of arterial revascularization within 16 weeks of Screening\n* History of acute coronary syndrome event within 24 weeks of Screening\n* Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening\n* Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study\n* History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening\n* New York Heart Association Class III-IV heart failure or last known ejection fraction of \\\u003C 30%\n* Current diagnosis of nephrotic syndrome\n* Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2\n* Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5× Upper Limit of Normal (ULN) at Screening\n\nNote: Additional Inclusion\u002FExclusion Criteria may apply per protocol",{"count":517,"type":22},288,[25],"This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.",[521],"Severe Hypertriglyceridemia",{"date":431,"type":40},{"date":524,"type":40},"2025-04-24",{"date":526,"type":22},"2029-06",{"name":528,"class":47},"Arrowhead Pharmaceuticals",95,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":558},"100573164","phase-3-a-phase-iii-renal-outcomes-and-cardiovascular-mortality-study-to-investigate-the-efficacy-and-safety-of-baxdrostat-in-combination-with-dapagliflozin-in-participants-with-chronic-kidney-disease-and-high-blood-pressure-100573164","NCT06742723","A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure","A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure","BaxDuo-Pacific","Inclusion Criteria:\n\n1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participants with (a) or (b):\n\n   a) eGFR 30-59 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 30 mg\u002Fg (3.39 mg\u002Fmmol) and \\\u003C 500 mg\u002Fg (56.5 mg\u002Fmmol) (central laboratory value only), or\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only).\n\n     (b) eGFR 60-75 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) ) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only)\n3. \\[obsolete\\]\n4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.\n5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.\n6. Participants with:\n\n   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol\u002FL if eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol\u002FL if eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n\nExclusion Criteria:\n\n1. Systolic blood pressure \\> 180 mmHg, or diastolic BP \\> 110 mmHg at screening.\n2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol\u002FL within 3 months at screening.\n3. Serum sodium \\\u003C 135 mmol\u002FL (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).\n\n4\\. Participants with T1DM will be excluded, except:\n\n1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.\n2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.\n\n   5 Uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol\u002Fmol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).\n\n   6 New York Heart Association functional HF class IV at screening.\n\n   7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.\n\n   8 Documented history of adrenal insufficiency.\n\n   9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.\n\n   10 Any acute kidney injury within 3 months prior to the Screening Visit.\n\n   11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).\n\n   12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).",{"count":539,"type":22},5000,[25],"International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure",[543],"Chronic Kidney Disease and Hypertension",[545,116,546,547,548,549,550],"Chronic kidney disease","Blood pressure","Baxdrostat","Dapagliflozin","Event-Driven","Outcome",{"date":431,"type":40},{"date":553,"type":40},"2025-03-03",{"date":555,"type":22},"2029-12-18",{"name":557,"class":47},"AstraZeneca",764,{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":141,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":585},"100563527","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dapirolizumab-pegol-in-study-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-100563527","NCT06617325","A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","PHOENYCS FLY","Inclusion Criteria:\n\n* Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)\n* Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:\n\n  a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \\\u003Clower limit of normal (LLN) OR complement C4 \\\u003CLLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:\n  1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)\n  2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)\u002FAnti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)\n  3. Historical evidence for anti-dsDNA antibodies\n  4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:\n\n     * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and\u002For a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND\n     * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND\n     * SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:\n     * Antimalarial treatment in combination with glucocorticoids and\u002For immunosuppressants or as stand-alone treatment if justified OR\n     * Treatment with glucocorticoids and\u002For immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)\n\n     Exclusion Criteria:\n* Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition\n* Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy\n* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \\[eg, curettage, electrodesiccation\\] not later than 4 weeks prior to the Screening Visit \\[V1\\]), basal cell carcinoma, or dermatological squamous cell carcinoma\n* Study participant has a mixed connective tissue disease, scleroderma, and\u002For overlap syndrome of these diseases with SLE\n* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study\n* Study participant has clinically significant active or latent infection\n* Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection\n* Study participants who have received live\u002Flive attenuated vaccines within 6 weeks prior to the first study medication infusion\n* Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol\n* Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP\n* Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP\n* Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2, or serum creatinine \\>2.5 mg\u002FdL, or participant has proteinuria \\>3g\u002Fday, or protein:creatinine ratio \\>340 mg\u002Fmmol at the Screening Visit",{"count":568,"type":22},450,[25],"The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.",[572],"Systemic Lupus Erythematosus",[574,575,576,577],"Systemic lupus erythematosus","Dapirolizumab pegol","SLE","DZP",{"date":431,"type":40},{"date":580,"type":40},"2024-11-21",{"date":582,"type":22},"2028-05-31",{"name":584,"class":47},"UCB Biopharma SRL",230,{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":599,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":610},"100559807","phase-2-a-study-to-assess-adverse-events-and-how-intravenously-iv-infused-telisotuzumab-vedotin-abbv-399-moves-through-the-body-as-a-monotherapy-in-adult-participants-with-previously-treated-non-squamous-non-small-cell-lung-cancer-nsclc-100559807","NCT06568939","A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced\u002FMetastatic Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Projected life expectancy of at least 12 weeks.\n* Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \\>= 25% tumor cells with 3+ staining (high \\[\\>= 50% 3+\\]; intermediate \\[\\>= 25% - \\\u003C 50%\\]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory\n* Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.\n* Must have a known epidermal growth factor receptor (EGFR) activating mutation status.\n* Actionable alterations in genes other than EGFR are permitted.\n* Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n* Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol.\n* Must have progressed on at least 1 line of prior therapy for locally advanced\u002Fmetastatic NSCLC, as stated in the protocol.\n\nExclusion Criteria:\n\n* Adenosquamous or neuroendocrine histology, or sarcomatoid features.\n* EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations).\n* Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.\n* Received prior docetaxel therapy.\n* Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.\n* History of other malignancies except those stated in the protocol.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol.\n* Unresolved clinically significant adverse event (AE) \\>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.\n* Major surgery within 21 days prior to randomization.\n* Clinically significant condition(s) including but not limited to those listed in the protocol.\n* Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.\n* Grade \\>= 2 edema or lymphedema.\n* Grade \\>= 2 ascites or pleural effusion.\n* Grade \\>= 2 neuropathy.\n* Active uncontrolled bacterial or viral infection.\n* Active corneal disorder.",{"count":594,"type":22},150,[84],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.\n\nTelisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide.\n\nParticipants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[598],"Non-Small Cell Lung Cancer",[598,600,601,602,603],"NSCLC","Telisotuzumab Vedotin","ABBV-399","TeliMET NSCLC-04",{"date":388,"type":40},{"date":606,"type":40},"2025-01-20",{"date":608,"type":22},"2028-02",{"name":304,"class":47},78,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":618,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":638},"100543874","phase-3-study-of-iv-human-plasma-derived-c1-esterase-inhibitor-concentrate-in-patients-with-congenital-c1-inh-deficiency-for-treatment-and-pre-procedure-preventing-of-acute-hereditary-angioedema-attacks-100543874","NCT06361537","Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks","Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks","Inclusion Criteria:\n\n1. Is at least 18 years of age (applicable for 1st study phase) or is at least 2 years of age (applicable for 2nd study phase)\n2. Has confirmed diagnosis of HAE type I or II\n3. Has had at least 3 moderate or severe HAE attacks (excluding extremity attacks) in the last 3 months before the Screening Visit. For participants ≥2 and ≤12 years of age, has had at least 1 moderate or severe HAE attack (excluding extremity attacks) in the last 6 months before Screening Visit\n4. Has a documented congenital C1-INH functional activity \\\u003C50% with or without C1-INH deficiency and C4 antigen level below the laboratory reference range\n5. Participant or the participant's legally authorized representative(s) has signed informed consent (as required by local law), with the assent of participants legally capable of providing it, as applicable\n6. States willingness to comply with all study procedures and availability for the duration of the study\n7. If the participant is of childbearing potential (CBP), has a negative pregnancy test and must have been using a highly effective method of contraception and continue to do so until at least 2 weeks after their last dose (for both blinded and open-label doses of IMP). Not of CBP is defined as surgically sterilized (hysterectomy, bilateral oophorectomy) or who are postmenopausal (defined as women with no menses for 12 months without an alternative medical cause). Highly effective methods of contraception:\n\n   * Combined hormonal contraception (estrogens and progesterone) methods such as oral, implantable, intravaginal, injectable, or transdermal contraceptives at a stable dose for a minimum of 1 full cycle (hormonal contraceptives must inhibit ovulation) and for at least 4 weeks before screening\n   * Progesterone only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n   * Intrauterine device\n   * Intrauterine hormone-releasing system inserted at least 4 weeks before screening\n   * Bilateral tubal ligation\u002Focclusion or vasectomized partner (with surgical success confirmed by medical assessment) OR Agrees to abstain from heterosexual intercourse during study participation and to use a highly effective contraceptive (as described above) as backup if they become sexually active during the study. Abstinence is only acceptable if this is the participant's usual lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception\n   * Note: If a participant of CBP has a positive or suspected positive urine pregnancy test within 72 hours prior to treatment, a serum pregnancy test will be required\n   * Male participants must not plan to father a child or donate sperm for 90 days after their last dose of study drug (for both blinded and open-label doses of the IMP). However, there are no official contraception requirements for male participants during the study.\n\nInclusion Criteria for IMP Dosing for QAT:\n\n1. Has confirmed QAT per definition criteria\n2. Has a swelling episode that is new and not the continuation of a previous HAE attack\n\nExclusion Criteria:\n\n1. Has a history of clinically relevant antibody development against C1-INH\n2. Has a medical history consistent with Type 3 HAE (i.e., onset at age above 40 year, no family history, no known HAE mutation, low C1q level in plasma)\n3. Has a history of allergic reaction to C1-INH or other blood\u002Fplasma product\n4. Has a history of B-cell malignancy that was unresolved in the past 5 years\n5. Has a narcotic and\u002For alcoholic addiction\n6. Has participated in any other investigational drug evaluation within 30 days before screening\n7. Is pregnant or breastfeeding\n8. Has any clinically significant medical or psychiatric condition that, in the investigator's opinion would interfere with the participant's ability to participate in the study\n9. Has a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within one year before screening\n10. (applicable until IDMC review of the interim preliminary safety and efficacy data): has clinically significant derangement in measurements of cardiovascular status (i.e. uncontrolled arterial hypertension, cardiac insufficiency New York Heart Association (NYHA) class III-IV), pulmonary status (i.e., COPD GOLD classification 3 and 4, severe asthma) and renal status (i.e., eGFR below 90 ml\u002Fmin per 1.73 m2)\n\nExclusion Criteria for IMP Dosing for QAT:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. started or changed hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) within 14 days before IMP dosing\n3. Started or changed androgen therapy (e.g. testosterone, dehydro- epiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) within 14 days before IMP dosing or is not willing to maintain a stable dose throughout the study\n4. Started or changed the dose of monoclonal antibodies e.g. lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing for a QAT\n6. Has received OCTA-C1-INH within 14 days before IMP dosing\n\nExclusion Criteria for IMP Dosing for PK:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. Is receiving hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) and has had their dose changed within 14 days before IMP dosing\n3. Is receiving or has received androgen therapy (e.g., testosterone, dehydroepiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) IN ANY DOSE within 14 days before dosing\n4. Started or changed the dose of monoclonal antibodies e.g lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing\n6. Has received IMP within 14 days before IMP dosing\n7. Has planned dental, medical, or surgical procedures during the PK Period that will require pre-procedural prevention","2 Years",{"count":620,"type":22},124,[25],"Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks",[624],"Acute Hereditary Angio Edema",[626,627,628,629,630],"Edema","Swelling","Angio Edema","Hereditary","Congenital Angioedema",{"date":269,"type":40},{"date":633,"type":40},"2024-04-30",{"date":635,"type":22},"2027-06",{"name":637,"class":47},"Octapharma",21,""]